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Trial Outcomes & Findings for The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL. (NCT NCT02263963)

NCT ID: NCT02263963

Last Updated: 2023-02-28

Results Overview

Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

participants will be followed for the duration of hospital stay, an expected average of 4 days

Results posted on

2023-02-28

Participant Flow

Participant milestones

Participant milestones
Measure
TAP Block Arm
Twenty five patients randomized to this arm. A volume of 7.5 ml of bupivacaine liposome injectable suspension was used for each side of the TAP blocks so that a total of 15 ml were utilized. The remaining 5 ml of bupivacaine liposome injectable suspension were diluted with 30 ml of sterile preservative free saline and used for local infiltration of the laparoscopic wound
no TAP Block Arm
Twenty five patients randomized to this arm. did not receive TAP block.
Overall Study
STARTED
25
25
Overall Study
COMPLETED
25
25
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TAP Block
n=25 Participants
Patient received TAP block
no TAP Block
n=25 Participants
patient did not received TAP block
Total
n=50 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
14 Participants
n=7 Participants
26 Participants
n=5 Participants
Age, Categorical
>=65 years
13 Participants
n=5 Participants
11 Participants
n=7 Participants
24 Participants
n=5 Participants
Age, Continuous
62.4 years
STANDARD_DEVIATION 13.9 • n=5 Participants
65.6 years
STANDARD_DEVIATION 12.5 • n=7 Participants
64 years
STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
14 Participants
n=7 Participants
25 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
11 Participants
n=7 Participants
25 Participants
n=5 Participants
Region of Enrollment
United States
25 participants
n=5 Participants
25 participants
n=7 Participants
50 participants
n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 4 days

Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.

Outcome measures

Outcome measures
Measure
TAP Block
n=25 Participants
post op pain score
no TAP Block
n=25 Participants
postop pain score
Postoperative Pain Score
4.2 units on a scale
Interval 0.5 to 8.5
4.5 units on a scale
Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 4 days

Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.

Outcome measures

Outcome measures
Measure
TAP Block
n=25 Participants
post op pain score
no TAP Block
n=25 Participants
postop pain score
Postoperative Narcotic Use
85 mg
Interval 0.0 to 311.0
110 mg
Interval 0.0 to 461.0

OTHER_PRE_SPECIFIED outcome

Timeframe: participants will be followed for the duration of hospital stay, and 30 days after discharge.

Any postoperative complications within 30 days of procedure, including death will be recorded.

Outcome measures

Outcome measures
Measure
TAP Block
n=25 Participants
post op pain score
no TAP Block
n=25 Participants
postop pain score
Postoperative Complications.
7 participants
9 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 4 days

Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.

Outcome measures

Outcome measures
Measure
TAP Block
n=25 Participants
post op pain score
no TAP Block
n=25 Participants
postop pain score
Length of Hospital Stay.
4 days
Interval 2.0 to 15.0
4 days
Interval 2.0 to 10.0

Adverse Events

TAP Block

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

no TAP Block

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nezar Jrebi

Spectrum Health

Phone: 507-271-8284

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place